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Evaluation of Optical Coherence Tomography. (ESSO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01080898
First received: January 28, 2010
Last updated: July 20, 2012
Last verified: April 2011
History of Changes
  Purpose

Determination of the sensitivity and specificity of different combinations of imaging techniques (spectral domain optical coherence tomography, fundus photography and fluorescein angiography) used for the diagnosis of choroidal neovessels complicating age -related macular degeneration. This information will help to determine the choice of the most suitable combination for the above diagnosis.


Condition Intervention
Age-Related Macular Degeneration
Choroidal Vessels; Anastomosis
 Other: tests

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Sensitivity and Specificity of Optical Coherence Tomography Combined With Fundus Color Photos for Diagnosis of Choroidal Neovessels in Age-related Macular Degeneration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photos in the diagnosis of choroidal neovessels in age- related macular degeneration. [ Time Frame: all outcome the day of inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the sensitivity and specificity of fluorescein angiography combined with fundus color photography in the diagnosis of choroidal neovessels in age - related macular degeneration. [ Time Frame: all the outcome the day of inclusion ] [ Designated as safety issue: No ]
  • Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photography, and of fluorescein angiography combined with fundus color photography. [ Time Frame: all outcome the day of inclusion ] [ Designated as safety issue: No ]
  • Rate of unusable images for each technique [ Time Frame: all outcome the day of inclusion ] [ Designated as safety issue: No ]
  • Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photography for the diagnosis of sub-categories of choroidal neovessels [ Time Frame: all outcome the day of inclusion ] [ Designated as safety issue: No ]
  • Evaluation of the sensitivity and specificity of fluorescein angiography combined with fundus color photography for the diagnosis of sub-categories of choroidal neovessels. [ Time Frame: all outcome the day of inclusion ] [ Designated as safety issue: No ]
  • Evaluation of the intra-and inter-reader reproducibility of the diagnosis of choroidal neovessels in age-related macular degeneration using fluorescein angiography combined with fundus color photography. [ Time Frame: all outcome the day of inclusion ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
DMLA patients
patients > 50 years with suspicion of choroidal neo-vessels complicating age related macular degeneration (DMLA)
 Other: tests
color photographs, FLUORESCEIN angiography and OCT

Detailed Description:

The following combinations will be studied: spectral domain optical coherence tomography (OCT) + fundus photography; fluorescein angiography + fundus photography and the combination of all three techniques (OCT+ fundus photography + fluorescein angiography).The sensitivity and specificity of the latter combination will be assessed by comparison with the results for this combination reported by several readers. Inter- and intra-observer reproducibility of the different combinations will also be studied.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients > 50 years with suspicion of choroidal neo-vessels complicating age relatid macular degeneration (DMLA)

Criteria

Inclusion Criteria:

  • Age> 50 years
  • First visit for suspicion of choroidal neo-vessels complicating age related macular degeneration
  • Fundus color photographs , FLUORESCEIN angiography and OCT prescription

Exclusion Criteria:

  • Age < 50 years
  • Diabetes
  • Central vein occlusion Macular hole Epi-retinal membrane Retinal detachment Macular hemorrhage more than the 1/3 of the lesion
  • History of macular laser, PDT or intra-vitreal injection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080898

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Ramin TADAYONI, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01080898     History of Changes
Other Study ID Numbers: K080904, IDRCB 2009-A00670-57
Study First Received: January 28, 2010
Last Updated: July 20, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Age - Related Macular Degeneration
Optical Coherence Tomography
Choroidal neovascularization
FLORESCEIN Angiography
Fundus photographs

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013